Drugs / Felodipine

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) PLENDIL — 1994-09-22 fda.gov ↗
Approved US (FDA) PLENDIL — 1991-07-25 fda.gov ↗

Trials 9

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT05614037 Oct → Nov 2022 hypertensive disorder Overseas Pharmaceuticals, Ltd. Unknown No outcome recorded
Phase 1 NCT02232269 Feb → Jun 2012 — London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Completed No outcome recorded
Phase 1 NCT00905333 Oct → Nov 2008 — AstraZeneca Completed No outcome recorded
Phase 45 trials
Phase 4 NCT04330300 Apr 2020 → Jul 2021 COVID-19, essential hypertension National University of Ireland, Galway, Ireland Suspended No outcome recorded Stop: Business
Phase 4 NCT00841880 Jan → Sep 2009 hypertensive disorder Sanofi Completed No outcome recorded
Phase 4 NCT00507845 Jun 2007 → Apr 2008 hypertensive disorder Sanofi Completed No outcome recorded
Phase 4 NCT00348686 Jun 2006 → Jun 2008 hypertensive disorder, hypertensive heart disease AstraZeneca Completed No outcome recorded
Phase 4 NCT00861016 Oct 2005 → Apr 2006 essential hypertension AstraZeneca Completed No outcome recorded
Phase not applicable1 trial
— NCT02336607 Dec 2005 → Jun 2006 hypertensive disorder AstraZeneca Completed No outcome recorded
Comparator or background therapy8 trials
Phase 3 NCT00679653 Comparator Feb 2002 → Dec 2003 hypertensive disorder, obesity disorder Abbott Completed No outcome recorded
Phase 3 NCT00000620 Background Sep 1999 → Jun 2009 atherosclerosis, coronary artery disorder, hyperlipoproteinemia, hypertensive disorder +1 National Heart, Lung, and Blood Institute (NHLBI) Completed Missed primary
Phase 4 NCT02744872 Comparator Sep 2013 → Jul 2016 disease related to solid organ transplantation Rigshospitalet, Denmark Completed No outcome recorded
Phase 4 NCT01520285 Comparator Dec 2011 → Mar 2013 essential hypertension Lee's Pharmaceutical Limited Completed No outcome recorded
Phase 4 NCT01238705 Comparator Apr 2008 → Oct 2010 essential hypertension, sexual disorder LanZhou University Unknown No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2012-08-21 Wockhardt Regulatory WOCKHARDT TO LAUNCH GENERIC VERSION OF ANTI – HYPERTENSIVE DRUG PLENDIL® wockhardt.com ↗

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 27 cited values

Every value below carries the sentence it was read from. 18 sources stand behind the page.

FieldValueCited text
Known as Felodipine “Amlodipine, diltiazem, felodipine, nicardipine, nifedipine, nimodipine, nitrendipine, verapamil” NCT04330300 ↗
16

“amlodipine, felodipine, isradipine, nicardipine, nifedipine” NCT00684489 ↗

“plendil (Felodipine)” NCT00000620 ↗

“felodipine/ramipril” NCT00679653 ↗

NCT00348686 ↗

NCT00507845 ↗

NCT02744872 ↗

NCT00861016 ↗

NCT01520285 ↗

NCT05614037 ↗

NCT02232269 ↗

Show 6 more sources

Known as C08CA02 ChEMBL registry synonym — accepted as the source's own label CHEMBL1480 ↗
Known as Cabren ChEMBL registry synonym — accepted as the source's own label CHEMBL1480 ↗
Known as Cardioplen xl ChEMBL registry synonym — accepted as the source's own label CHEMBL1480 ↗
Known as Felodipine component of lexxel ChEMBL registry synonym — accepted as the source's own label CHEMBL1480 ↗
Known as Felodipine Controlled Release Tablets “Test preparation (T) :Felodipine Controlled Release Tablets Specification: 5 mg Batch number: 22090301 Content: 100.8% Valid until: September 2024 Storage conditions: sealed,...” NCT05614037 ↗
Known as Felodipine Modified-release Tablets “Felodipine Modified-release Tablets (trade name:plendil ®) Specification: 5 mg Batch number: 2204 a11 Content: 99.1% Valid until March 2025 Storage conditions: below 25℃...” NCT05614037 ↗
Known as Felodipine sustained release tablets “Felodipine sustained release tablets (trade name: plendil®)” NCT05614037 ↗
Known as Felodipine sustained-release tablet “Felodipine sustained-release tablet (5mg/tablet)” NCT01520285 ↗
Known as Felodipino ChEMBL registry synonym — accepted as the source's own label CHEMBL1480 ↗
Known as Felogen xl ChEMBL registry synonym — accepted as the source's own label CHEMBL1480 ↗
Known as Felotens xl ChEMBL registry synonym — accepted as the source's own label CHEMBL1480 ↗
Known as Folpik xl ChEMBL registry synonym — accepted as the source's own label CHEMBL1480 ↗
Known as H 154/82 ChEMBL registry synonym — accepted as the source's own label CHEMBL1480 ↗
Known as Keloc sr ChEMBL registry synonym — accepted as the source's own label CHEMBL1480 ↗
Known as Neofel xl ChEMBL registry synonym — accepted as the source's own label CHEMBL1480 ↗
Known as NSC-760343 ChEMBL registry synonym — accepted as the source's own label CHEMBL1480 ↗
Known as Parmid xl ChEMBL registry synonym — accepted as the source's own label CHEMBL1480 ↗
Known as Pinefeld xl ChEMBL registry synonym — accepted as the source's own label CHEMBL1480 ↗
Known as Plendil “Felodipine sustained release tablets (trade name: plendil®)” NCT05614037 ↗
1

“Felodipine tablet (Plendil) alone” NCT02336607 ↗

Known as plendil (Felodipine) “plendil (Felodipine)” NCT00000620 ↗
Known as Preslow ChEMBL registry synonym — accepted as the source's own label CHEMBL1480 ↗
Known as Vascalpha ChEMBL registry synonym — accepted as the source's own label CHEMBL1480 ↗
Action Inhibit “Mineralocorticoid receptor antagonist” CHEMBL1480 ↗
Modality Small molecule — CHEMBL1480 ↗